
AOTI CEO Dr. Mike Griffiths joined Steve Darling from Proactive to discuss a major regulatory milestone after the Centers for Medicare & Medicaid Services (CMS) issued a proposed Local Coverage Determination (LCD) supporting the use of topical oxygen therapy for diabetic foot ulcers that have failed to heal after four weeks of optimized care. Griffiths said that following a 45-day public comment period, CMS is expected to finalize the LCD within the next year. Once approved, the policy would establish Medicare coverage and reimbursement criteria for AOTI's TWO2® intermittent topical wound oxygen therapy, significantly expanding patient access across the United States. Management believes the final LCD will be transformative, providing access to approximately 69 million Medicare beneficiaries, including a population with high rates of diabetes and diabetic foot ulcers. The company also expects the decision to accelerate reimbursement across Medicaid, commercial insurers, and manag...